USA - FDA official clarifies misconceptions around RWE in premarket submissions

Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference. “[R]eal world evidence is just clinical evidence. There aren’t two things that we should be thinking about differently,” Felipe Aguel, deputy director in the Office of Clinical Evidenc...